Dataset from A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Rilpivirine From Current INI-, NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-Infected Adults Who Are Virologically Suppressed

The aim of this study is to determine if virologically suppressed human immunodeficiency
virus type 1 (HIV-1) infected adults on an antiretroviral regimen (including 2 nucleoside
reverse transcriptase inhibitors [NRTIs] plus a third agent) remain suppressed upon switching
to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV). The study will primarily
assess the non-inferiority antiviral activity of switching to DTG + RPV once daily compared
to continuation of current antiretroviral regimen (CAR) up to Week 48 with a switch visit for
eligible subjects in the CAR group to initiate DTG + RPV therapy at Week 52. CAR will include
2 NRTIs plus 1 HIV-1 integrase inhibitor (INI), or 1 non-nucleoside reverse transcriptase
inhibitor (NNRTI), or 1 protease inhibitor (PI). The study will include a 148-week open-label
treatment phase, comprising of an Early Switch Phase (Day 1 to Week 52) and a Late Switch
Phase (Week 52 to Week 148). The participants fulfilling the study eligibility criteria will
participate in the Early Switch Phase where they will either switch from their CAR to DTG +
RPV, or continue taking their CAR, until Week 52. At the end of Early Switch Phase, eligible
participants will proceed to the Late Switch Phase where all participants in both DTG + RPV
and CAR treatment groups will receive DTG + RPV therapy until Week 148. After Week 148,
subjects may be eligible to continue to receive DTG +RPV in the Continuation Phase. The study
is planned to be conducted in approximately 476 participants.